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IRCT20231106059970N1 IRCT 2023-11-19 Shahid Beheshti University of Medical Sciences Comparing the effectiveness of four transdiagnostic among adults and adolescences Comparing the effectiveness of four transdiagnostic treatments on reduction of symptoms of emotional disorders and Cluster B personality disorders among adults and adolescences 2023-12-22 anticipated 360 Complete https://irct.ir/trial/73577 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The G*Power software will be used for calculating sample size by indicating the margin of error of 0.05 and power of 0.95 total sample size will be 180 for adolescent and 180for adult sample size. 180 participants of adolescents will be randomly allocated in four groups by using https://www.dcode.fr/random-selection and after that each group will received one of the treatments randomly. this will be done for adult group, too, Blinding description: In the current study, participants will received a code for registering in study, after allocation randomly in treatment groups, therapists who will be blinded to participants diagnosis, will apply treatments. After intervention finish, the assessors who will be blind to participants diagnosis and type of intervention will analysis data. Finally, the observer, the only person who know who receive which treatment will write the report. N/A Condition 1: Individuals who meet the full criteria of emotional disorders including mood disorders, anxiety disorders, OCD, PTSD,and eating disorder. Condition 2: Individuals who meet the full criteria of emotional disorders including mood disorders, anxiety disorders, OCD, PTSD, and eating disorders. Condition 3: Individuals who meet the full criteria of emotional disorders including mood disorders, anxiety disorders, OCD, PTSD, and eating disorders. Condition 4: Individuals who meet the full criteria of emotional disorders including mood disorders, anxiety disorders, OCD, PTSD,and eating disorders. Condition 5: Individuals who meet the full criteria of emotional disorders including mood disorders, anxiety disorders, OCD, PTSD, and eating disorders. Condition 6: Individuals who meet the full criteria of cluster B personality disorders consists of antisocial personality disorder, borderline personality disorder, narcissistic personality. Condition 7: Individuals who meet the full criteria of cluster B personality disorders consists of antisocial personality disorder, borderline personality disorder, narcissistic personality. Condition 8: Individuals who meet the full criteria of cluster B personality disorders consists of antisocial personality disorder, borderline personality disorder, narcissistic personality. Condition 9: Individuals who meet the full criteria of cluster B personality disorders consists of antisocial personality disorder, borderline personality disorder, narcissistic personality. Intervention 1: Intervention group: Adaptation of Unified protocol for adolescents which consists 8 - 15weekly45-60 minutes session. Primary care-giver can participate in this treatment weekly either 2-5 individuals sessions. Intervention 2: Intervention group: Unified protocol consists 8-14 weekly session that last between 45-60 minutes. main modules based on each participants conceptualization will be applied. Intervention 3: Intervention group: Modified Dialectical behaviour therapy (DBT) for adolescents consists of weekly individual therapy sessions (approximately 1 hour), a weekly group skills training session (approximately 1.5–2.5 hours), and a therapist consultation team meeting (approximately 1–2 hours) that can last for 20 sessions. Intervention 4: Intervention group: Dialectical behaviour therapy (DBT)The standard DBT treatment package consists of weekly individual therapy sessions (approximately 1 hour), a weekly group skills training session (approximately 1.5–2.5 hours), and a therapist consultation team meeting (approximately 1–2 hours). Intervention 5: Intervention group: Modified mentalization-based treatment for adolescents (MBT-A) is a manualized, psychodynamic psychotherapy based on attachment theory . It consists of 50 minutes of individual weekly and family monthly sessions and lasts for one -year. Intervention 6: Intervention group: Mentalization-based treatment for adults is a manualized, psychodynamic psychotherapy based on attachment theory . It consists of 50 minutes of individual weekly and family monthly sessions and lasts for one -year. Intervention 7: Intervention group: َmodification version of Self-Acceptance Group Therapy (SAGT) is 12, 90-minute weekly sessions and will be applied in small groups of six participants and focuses on shame, acceptance and emotion regulation. Intervention 8: Intervention group: Self-Acceptance Group Therapy (SAGT) is 12, 90-minute weekly sessions and will be applied in small groups of six participants and focuses on shame, acceptance and emotion regulation. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is for reasonable requests the data will be shared
public Banafsheh Mohajerin
psychology department,4 floor, taleqani Hospiotal, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1985717443 +98 912 578 6918 banafshehmohajerin@gmail.com Shahid Beheshti University of Medical Sciences scientific banafsheh mohajerin
Psychology department, 4ّFloor, Taleqani Hospital, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1985717443 +98 912 578 6918 banafshehmohajerin@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age between 11-18 in adolescence sample Age between 18 to 65 in adults group Be able to read and speak Farsi fluently, participant in in-person psychotherapy sessions Adolescence sample meet full criteria for at least one emotional disorders In Adult sample: meet full criteria for at least one emotional disorders and /or cluster B personality disorders 11 years 65 years Both active suicidal plan substance dependency, meet criteria as schizophrenia and neurological diseases psychiatry medicines miss more than three psychotherapy session repeatedly F33 F41.1 F42 F43.1 F50 F60.2 F60.3 F60.81 F60.4 Major depressive disorder, recurrent Generalized anxiety disorder Obsessive-compulsive disorder Post-traumatic stress disorder (PTSD) Eating disorders Antisocial personality disorder Borderline personality disorder Narcissistic personality disorder Histrionic personality disorder Treatment - Other Treatment - Other Treatment - Other Treatment - Other Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group: Adaptation of Unified protocol for adolescents which consists 8 - 15weekly45-60 minutes session. Primary care-giver can participate in this treatment weekly either 2-5 individuals sessions Intervention group: Unified protocol consists 8-14 weekly session that last between 45-60 minutes. main modules based on each participants conceptualization will be applied Intervention group: Modified Dialectical behaviour therapy (DBT) for adolescents consists of weekly individual therapy sessions (approximately 1 hour), a weekly group skills training session (approximately 1.5–2.5 hours), and a therapist consultation team meeting (approximately 1–2 hours) that can last for 20 sessions Intervention group: Dialectical behaviour therapy (DBT)The standard DBT treatment package consists of weekly individual therapy sessions (approximately 1 hour), a weekly group skills training session (approximately 1.5–2.5 hours), and a therapist consultation team meeting (approximately 1–2 hours) Intervention group: Modified mentalization-based treatment for adolescents (MBT-A) is a manualized, psychodynamic psychotherapy based on attachment theory . It consists of 50 minutes of individual weekly and family monthly sessions and lasts for one -year. Intervention group: Mentalization-based treatment for adults is a manualized, psychodynamic psychotherapy based on attachment theory . It consists of 50 minutes of individual weekly and family monthly sessions and lasts for one -year. Intervention group: َmodification version of Self-Acceptance Group Therapy (SAGT) is 12, 90-minute weekly sessions and will be applied in small groups of six participants and focuses on shame, acceptance and emotion regulation Intervention group: Self-Acceptance Group Therapy (SAGT) is 12, 90-minute weekly sessions and will be applied in small groups of six participants and focuses on shame, acceptance and emotion regulation Scores of Beck's Depression Inventory (BDI-II). Timepoint: questionnaires will be assessed at baseline, post-treatment, 6,12,18,24 and 36-month follow-up. Method of measurement: Beck's Depression Inventory (BDI-II). Scores of Beck's anxiety Inventory (BAI). Timepoint: questionnaires will be assessed at baseline, post-treatment, 6,12,18,24 and 36-month follow-up. Method of measurement: Beck's anxiety Inventory (BAI). Scores of the Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004). Timepoint: questionnaires will be assessed at baseline, post-treatment, 6,12,18,24 and 36-month follow-up. Method of measurement: The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004). Scores of the Positive and Negative Affect Schedule (PANAS). Timepoint: questionnaires will be assessed at baseline, post-treatment, 6,12,18,24 and 36-month follow-up. Method of measurement: The Positive and Negative Affect Schedule (PANAS) (Watson, Clark, & Tellegen, 1988). Scores of Shame severity. Timepoint: baseline, post- treatment, 6,12,18,24 and 36 months follow-up. Method of measurement: The Experience of Shame Scale (ESS, Andrews et al, 2002). Shahid Beheshti University of Medical Sciences Approved 2023-10-29 Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me Ethic commitee of Shahid Beheshti University of Medical Sciences, 6 floor, 2th Building, Arabi St, Velenjak,Tehran, Iran Tehran Tehran Iran (Islamic Republic of)